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Plavix (Clopidogrel Bisulfate) - Summary

 
 



WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS

The effectiveness of Plavix is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions]. Plavix at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with Plavix at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy [see Clinical Pharmacology]. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers [see Dosage and Administration].

 

PLAVIX SUMMARY

Plavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors.

PLAVIX (clopidogrel) is indicated for the following:

Acute Coronary Syndrome (ACS)

  • For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
  • For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.

The optimal duration of Plavix therapy in ACS is unknown.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Plavix has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.


See all Plavix indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Plavix (Clopidogrel)

Initial 3-Weeks' Apixaban Versus Dual-Antiplatelet Therapy (Clopidogrel and Aspirin) Followed by Clopidogrel Alone in High-Risk Patients with Acute Non-Disabling Cerebrovascular Events (ADANCE): Study Protocol for a Randomized Controlled Trial. [2014]
BACKGROUND: Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial demonstrated that dual-antiplatelet therapy (clopidogrel and aspirin), compared with aspirin monotherapy, reduced the risk of recurrent stroke and was not associated with increased risk of hemorrhagic events...

Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. [2014]
effects on platelets... CONCLUSIONS: Morphine delays clopidogrel absorption, decreases plasma levels of

A comparative evaluation of prasugrel and clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention. [2013]
patients were also assessed for safety of the drugs... CONCLUSION: This study suggests that prasugrel is more effective than clopidogrel

Concomitant administration of clopidogrel with statins or calcium-channel blockers: insights from the TRITON-TIMI 38 (trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-thrombolysis in myocardial infarction 38). [2013]
blockers (CCBs) may attenuate the pharmacodynamic effects of clopidogrel... CONCLUSIONS: In patients with ACS undergoing PCI, the use of statins or CCBs was

Gastrointestinal adverse events after dual antiplatelet therapy: clopidogrel is safer than ticagrelor, but prasugrel data are lacking or inconclusive. [2013]
Current guidelines offer a choice of P2Y12 receptor antagonist among clopidogrel, prasugrel or ticagrelor on top of aspirin (ASA) for dual antiplatelet therapy (DAPT) in patients after acute coronary syndromes (ACS). However, the comparative risks of gastrointestinal (GI) adverse events during DAPT are not clear...

more studies >>

Clinical Trials Related to Plavix (Clopidogrel)

Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery. [Completed]

- Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing

Coronary Artery Bypass Surgery

- Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass grafting.

Is surgical delay necessary in patients using clopidogrel? And if so, which is the safety time interval when clopidogrel should be stopped before surgery in order to avoid bleeding and other related complications.

- Background: By blockade of the platelet ADP receptor, clopidogrel inhibits the binding

of fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing platelet aggregation from ADP stimulation. Some authors suggest that the platelet function is completely recovered in 7 days after stopping clopidogrel in healthy subjects. Other researches suggest full recovery of platelet function in 3 to 5 days.

- Study objectives: To investigate if the interruption of the clopidogrel is necessary

before CABG in order to prevent bleeding and other complications. To trace the increased risk patients for postoperative bleeding and to individualize the therapy according to TEG measurements.

- Design: A prospective, randomized mono- center study

- Patients: Patients who are receiving elective or urgent CABG surgery and are

pre-treated at least 5 days before surgery with clopidogrel

- Primary endpoint: To determine if there are significant differences in blood loss,

transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using Clopidogrel.

- Secondary endpoints: Death, myocardial infarction, stroke, respiratory failure, renal

failure requiring dialysis, mediastinitis,readmission rates within 30 days from discharge, and ICU and hospital lengths of stay

- Risks: Using standard dose of aprotinin, we consider no increased risk in blood loss

and other related complications for this three groups of patients.

- Possible benefits: Reduction of time delay in operating patients under treatment with

clopidogrel. A more accurate time interval when clopidogrel should be stopped before surgery in order to eliminate the risk of bleeding and associated complications.

Clopidogrel Bioequivalence Study in Healthy Subjects [Completed]
This study will be an open-label, randomised, three-way crossover study in healthy male and female subjects, performed at a single centre. The objective of the study is to assess the bioequivalence between one test formulation (Clopidogrel 75 mg tablet (commercial blister from KRKA) and two reference formulations (Clopidogrel 75 mg tablet [Plavix, sourced in US and Japan]).

Clopidogrel PGX Bench to Bedside [Completed]
Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population whose genes are well known in order to determine the role that genes play in the response to various clopidogrel maintenance doses.

Aspirin and Plavix Following Coronary Artery Bypass Grafting [Terminated]
The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.

A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants. [Completed]

more trials >>

Reports of Suspected Plavix (Clopidogrel) Side Effects

Death (186)Gastrointestinal Haemorrhage (126)Dyspnoea (115)Anaemia (109)Myocardial Infarction (104)Contusion (90)Haemorrhage (74)Asthenia (72)Fall (70)Cerebrovascular Accident (68)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Plavix has an overall score of 7.75. The effectiveness score is 8.50 and the side effect score is 8.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Plavix review by 65 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   R.A.
Dosage & duration:   200 mg taken twice per day for the period of 7 yrs.
Other conditions:   None
Other drugs taken:   Meloxicam 7.5 mg (Mobic)
  
Reported Results
Benefits:   This regimen eliminated, for the most part, the pain, stiffness, and exhaustion experienced with rheumatoid arthritis.
Side effects:   No side effects at all, other than returning me to an apparently more normal state of health.
Comments:   Initially, stronger drugs such as cortisone were needed to control and stabilize the rheumatoid arthritis. Once that was accomplished, the Plavix/Mobic treatment has been consistently effective for quite a few years.

 

Plavix review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   strokes
Dosage & duration:   75mg taken 1 per day for the period of About 5 years and continuing
Other conditions:   high bad cholesterol, elevated blood pressure
Other drugs taken:   ramapril, lipitor
  
Reported Results
Benefits:   Since starting the plavix and other meds, I have had no strokes.
Side effects:   Terrible bruising. If I bump my fingers, the joints will swell.
Comments:   I've had one stroke and 15 T.I.A.s. It is a genetic problem, but I have fully recovered from all. The first was in my 30's. I eat a very healthy, low fat, vegetarian diet and I excercise regularily. The meds I take are necessary, however a healthy, acitve lifestyle is critical.

 

Plavix review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   strokes
Dosage & duration:   75mg taken 1 per day for the period of About 5 years and continuing
Other conditions:   high bad cholesterol, elevated blood pressure
Other drugs taken:   ramapril, lipitor
  
Reported Results
Benefits:   Since starting the plavix and other meds, I have had no strokes.
Side effects:   Terrible bruising. If I bump my fingers, the joints will swell.
Comments:   I've had one stroke and 15 T.I.A.s. It is a genetic problem, but I have fully recovered from all. The first was in my 30's. I eat a very healthy, low fat, vegetarian diet and I excercise regularily. The meds I take are necessary, however a healthy, acitve lifestyle is critical.

See all Plavix reviews / ratings >>

Page last updated: 2014-11-30

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